• Journal of Korean Neurosurgical Society
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• v.59 no.2
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• pp.91-97
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• 2016

Objective : To investigate the biomechanical effects of a newly proposed Interspinous Process Compressor (IPC) and compare with pedicle screw fixation at surgical and adjacent levels of lumbar spine. Methods : A three dimensional finite element model of intact lumbar spine was constructed and two spinal fusion models using pedicle screw fixation system and a new type of interspinous devices, IPC, were developed. The biomechanical effects such as range of motion (ROM) and facet contact force were analyzed at surgical level (L3/4) and adjacent levels (L2/3, L4/5). In addition, the stress in adjacent intervertebral discs (D2, D4) was investigated. Results : The entire results show biomechanical parameters such as ROM, facet contact force, and stress in adjacent intervertebral discs were similar between PLIF and IPC models in all motions based on the assumption that the implants were perfectly fused with the spine. Conclusion : The newly proposed fusion device, IPC, had similar fusion effect at surgical level, and biomechanical effects at adjacent levels were also similar with those of pedicle screw fixation system. However, for clinical applications, real fusion effect between spinous process and hooks, duration of fusion, and influence on spinous process need to be investigated through clinical study.

• Proceedings of the Korean Society of Precision Engineering Conference
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• 2004.10a
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• pp.1207-1210
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• 2004

As many humans age, degenerative lumbar spinal stenosis (DLSS) becomes a major cause of lower limb discomfort and disability. By surgical treatment method of DLSS, the existing surgical treatment methods using internal fixation have showed degeneration changes of an adjacent vertebrae and loss of lumbar spine lordosis-kyphosis due to eliminating a motion. For solving the problems of internal fixation, a novel interspinous spacer has been developed to treat DLSS by surgical treatment method. In this study, we evaluated the biomechanical effects of the interspinous spacer on the kinematics of the porcine lumbar spine before and after insertion of the implant. For this purpose, a device that is capable of measuring 3-D motions were built based on direct linear transformation (DLT) algorithm written with MATLAB program. Results showed that in extension, a change of the mean angle between the intact and the implanted specimens at L4-L5 was 1.87 degree difference and the implant reduced the extension range of motion of the L4-L5 (p＆lt;0.05). But the range of motion in flexion, axial rotation and lateral bending at the adjacent segments was not statistically affected by the implant. In conclusion, we thought that interspinous spacer may have remedical value for DLSS by flexing human lumbar spine.

• Journal of Korean Neurosurgical Society
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• v.46 no.5
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• pp.425-430
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• 2009

Objective : The present study analyzed the risk factors, prevalence and clinical results following revision surgery for adjacent segment degeneration (ASD) in patients who had undergone lumbar fusion. Methods : Over an 8-year period, we performed posterior lumbar fusion in 81 patients. Patients were followed a minimum of 2 years (mean 5.5 years). During that time, 9 patients required revision surgery due to ASD development. Four patients underwent autogenous posterolateral arthrodesis and extended transpedicle screw fixation, 4 patients underwent decompressive laminectomy and interspinous device implantation, and 1 patient underwent simple decompression. Results : Of the 9 of patients with clinical ASD, 33.3% (3 of 9) of patients did not have radiographic ASD on plain radiographs. Following revision surgery, the clinical results were excellent or good in 8 patients (88.9%). Age > 50 years at primary surgery was a significant risk factor for ASD development, while number of fusion levels, initial diagnosis and type of fusion were not. Conclusion : The incidence of ASD development after lumbar surgery was 11.1% (9 of 81) in this study. Age greater than 50 was the statistically significant risk factor for ASD development. Similar successful clinical outcomes were observed after extended fusion with wide decompression or after interspinous device implantation. Given the latter procedure is less invasive, the findings suggest it may be considered a treatment alternative in selected cases but it needs further study.

• Journal of Biomedical Engineering Research
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• v.36 no.6
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• pp.276-282
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• 2015

Recently, during the multi-level fusion with pedicle screws, interspinous spacer are sometimes substituted for the most superior level of the fusion in an attempt to reduce the number of fusion level and likelihood of degeneration process at the adjacent level. In this study, a finite element (FE) study was performed to assess biomechanical efficacies of the interspinous spacer combined with posterior lumbar fusion with a previously-validated 3-dimensional FE model of the intact lumbar spine (L1-S1). The post-operative models were made by modifying the intact model to simulate the implantation of interspinous spacer and pedicle screws at the L3-4 and L4-5. Four different configurations of the post-op model were considered: (1) a normal spinal model; (2) Type 1, one-level fusion using posterior pedicle screws at the L4-5; (3) Type 2, two-level (L3-5) fusion; (4) Type 3, Type 1 plus Coflex$^{TM}$ at the L3-4. hybrid protocol (intact: 10 Nm) with a compressive follower load of 400N were used to flex, extend, axially rotate and laterally bend the FE model. As compared to the intact model, Type 2 showed the greatest increase in Range of motion (ROM) at the adjacent level (L2-3), followed Type 3, and Type 1 depending on the loading type. At L3-4, ROM of Type 2 was reduced by 34~56% regardless of loading mode, as compared to decrease of 55% in Type 3 only in extension. In case of normal bone strength model (Type 3_Normal), PVMS at the process and the pedicle remained less than 20% of their yield strengths regardless of loading, except in extension (about 35%). However, for the osteoporotic model (Type 3_Osteoporotic), it reached up to 56% in extension indicating increased susceptibility to fracture. This study suggested that substitution of the superior level fusion with the interspinous spacer in multi-level fusion may be able to offer similar biomechanical outcome and stability while reducing likelihood of adjacent level degeneration.

• Journal of Korean Neurosurgical Society
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• v.52 no.4
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• pp.359-364
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• 2012

Objective : Transpedicular screw fixation has some disadvantages such as postoperative back pain through wide muscle dissection, long operative time, and cephalad adjacent segmental degeneration (ASD). The purposes of this study are investigation and comparison of radiological and clinical results between interspinous fusion device (IFD) and pedicle screw. Methods : From Jan. 2008 to Aug. 2009, 40 patients underwent spinal fusion with IFD combined with posterior lumbar interbody fusion (PLIF). In same study period, 36 patients underwent spinal fusion with pedicle screw fixation as control group. Dynamic lateral radiographs, visual analogue scale (VAS), and Korean version of the Oswestry disability index (K-ODI) scores were evaluated in both groups. Results : The lumbar spine diseases in the IFD group were as followings; spinal stenosis in 26, degenerative spondylolisthesis in 12, and intervertebral disc herniation in 2. The mean follow up period was 14.24 months (range; 12 to 22 months) in the IFD group and 18.3 months (range; 12 to 28 months) in pedicle screw group. The mean VAS scores was preoperatively $7.16{\pm}2.1$ and $8.03{\pm}2.3$ in the IFD and pedicle screw groups, respectively, and improved postoperatively to $1.3{\pm}2.9$ and $1.2{\pm}3.2$ in 1-year follow ups (p<0.05). The K-ODI was decreased significantly in an equal amount in both groups one year postoperatively (p<0.05). The statistics revealed a higher incidence of ASD in pedicle screw group than the IFD group (p=0.029) Conclusion : Posterior IFD has several advantages over the pedicle screw fixation in terms of skin incision, muscle dissection and short operative time and less intraoperative estimated blood loss. The IFD with PLIF may be a favorable technique to replace the pedicle screw fixation in selective case.

• Journal of Korean Neurosurgical Society
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• v.46 no.4
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• pp.292-299
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• 2009

Objective : Clinical and radiological results of posterior dynamic stabilization using interspinous U (ISU, $Coflex^{TM}$, Paradigm Spine $Inc.^{(R)}$, NY, USA) were analyzed in comparison with posterior lumbar interbody fusion (PLIF) in degenerative lumbar spinal stenosis (LSS). Methods : A retrospective study was conducted for a consecutive series of 61 patients with degenerative LSS between May 2003 and December 2005. We included only the patients completed minimum 24 months follow up evaluation. Among them, 30 patients were treated with implantation of ISU after decompressive laminectomy (Group ISU) and 31 patients were treated with wide decompressive laminectomy and posterior lumbar interbody fusion (PLIF; Group PLIF). We evaluated visual analogue scale (VAS) and Oswestry Disability Index (ODI) for clinical outcomes (VAS, ODI), disc height ratio disc height (DH), disc height/vertebral body length ${\times}100$), static vertebral slip (VS) and depth of maximal radiolucent gap between ISU and spinous process) in preoperative, immediate postoperative and last follow up. Results : The mean age of group ISU ($66.2{\pm}6.7$ years) was 6.2 years older than the mean age of group PLIF ($60.4{\pm}8.1$ years; p=0.003). In both groups, clinical measures improved significantly than preoperative values (p<0.001). Operation time and blood loss was significantly shorter and lower in group ISU than group PLIF (p<0.001). In group ISU, the DH increased transiently in immediate postoperative period ($15.7{\pm}4.5%{\rightarrow}18.6{\pm}5.9%$), however decreased significantly in last follow up ($13.8{\pm}6.6%$, p=0.027). Vertebral slip (VS) of spondylolisthesis in group ISU increased during postoperative follow-up ($2.3{\pm}3.3{\rightarrow}8.7{\pm}6.2$, p=0.040). Meanwhile, the postoperatively improved DH and VS was maintained in group PLIF in last follow up. Conclusion : According to our result, implantation of ISU after decompressive laminectomy in degenerative LSS is less invasive and provides similar clinical outcome in comparison with the instrumented fusion. However, the device has only transient effect on the postoperative restoration of disc height and reduction of slip in spondylolisthesis. Therefore, in the biomechanical standpoint, it is hard to expect that use of Interspinous U in decompressive laminectomy for degenerative LSS had long term beneficial effect.

• Journal of Biomedical Engineering Research
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• v.27 no.5
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• pp.210-217
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• 2006

Many types of interspinous distraction devices (IDDs) have been recently developed as an alternative surgical treatment to laminectomy and fusion with pedicle screws for the treatment of the lumbar spinal stenosis (LSS). They are intended to keep the lumbar spine in a slightly flexed posture to relieve pain caused by narrowing of the spinal canal and vertebral foramen. However, their biomechanical efficacies are not well known. In this study, we evaluated the kinematic behaviors and changes in intradiscal pressure (IDP) of the porcine lumbar spine implanted with IDD. For kinematics analysis, five porcine lumbar spines (L2-L6) were used and the IDD was inserted at L4-L5. Three markers (${\phi}{\le}0.8mm$) were attached on each vertebra to define a rigid body motion for stereophotogrammetric assessment of the spinal motion in 3-D. A moment of 7.5Nm in flexion-extension, lateral bending, and axial rotation were imparted with a compressive force of 700N. Then, IDD was implanted at L3-L4. IDPs were measured using pressure transducer under compression (700N) and additional extension moment (700N+7.5Nm). In kinematic behaviors, insertion of IDD resulted in statistically significant decrease 42.8% at the implanted level in extension. There were considerable changes in ROM at the adjacent levels, but statistically insignificant. In other motions, there were no significant changes in ROM as well regardless of levels. IDPs at the surgical level (L3-L4) under compression and extension moment decreased by 12.9% and 18.8% respectively after surgery (p<0.05). At the superiorly adjacent levels, IDPs increased by 19.4% and 12.9% under compression and extension, respectively (p<0.05). Corresponding changes at the inferiorly adjacent levels were 29.4% and 6.9%, but they were statistically insignificant (p>0.05). The magnitude of pressure changes due to IDD, both at the operated and adjacent levels, were far less than the previously reported values with conventional fusion techniques. Our experimental results demonstrated the IDDs can be very effective in limiting the extension motion that may cause narrowing of the spinal canal and vertebral foramens while maintaining kinematic behaviors and disc pressures at the adjacent levels.

• Journal of Korean Neurosurgical Society
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• v.47 no.5
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• pp.338-344
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• 2010

Objective : This study assessed the safety and efficacy of one level unilateral laminotomy bilateral decompression (ULBD) with the placement of a device for intervertebral assisted motion (DIAM) compared with one level ULBD only in elderly patients with degenerative lumbar spinal stenosis (DLSS). Methods : A non randomized prospective analysis was performed on 16 patients who underwent one level ULBD with DIAM (Group A) and 20 patients with one level ULBD only (Group B) between February 2007 and March 2008. Radiographic imaging, visual analog scale (VAS) and MacNab outcome scale were obtained before and after surgery at a mean interval of 21 months (range 17-27 months). Results : The disc height, interpedicular distance, slip distance and segmental lordotic angle were similar between two groups. In the group A, there was no significant difference between the pre- and post-operative imaging in terms of the sagittal balance and disc height. Both groups showed significant improvement in the clinical outcomes. In addition, there was significantly less low-back pain in the group A than in the group B at the last follow up, while the clinical improvement of the leg pain and MacNab outcome scale showed no significant difference in the two groups. There were no major complications or DIAM associated complications. Conclusion : ULBD with DIAM is a safe and efficacious treatment for selective elderly patients with DLSS, particularly for relieving low back pain comparing to ULBD. ULBD with DIAM did not alter the disc height or sagittal alignment at the mean 21 months follow-up interval.